title: An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation.
abstract: Acutely ill, schizophrenic patients frequently require management of agitation. This study was conducted to compare the efficacy of oral zotepine and risperidone in hospitalized, acutely ill schizophrenic patients with symptoms of agitation.This was a 6-week, multicenter, randomized, open-label, parallel-group, flexible dosing study. Thirty-nine patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who met the criteria of a Positive and Negative Syndrome Scale (PANSS) total score of greater than or equal to 60 points, PANSS-excitement component (EC) score of greater than or equal to 14 points, and at least 1 PANSS-EC score of greater than or equal to 4 were randomly assigned to either the zotepine or risperidone group. The primary outcome was a comparison of the change in the PANSS-EC total score from baseline to the end of the study between groups.There was no significant between-group difference in dropout rates (zotepine, 15.8% [3/19]; risperidone, 20.0% [4/20]). The mean (SD) daily dose of zotepine from baseline to study end point ranged from 127.6 (62.3) to 236.8 (74.2) mg/d; the corresponding values for risperidone ranged from 3.3 (1.6) to 4.8 (1.7) mg/d. There were no statistically significant differences in patient characteristics, PANSS total score, and PANSS-EC total score between the zotepine and risperidone groups at baseline. Both groups showed significant reductions in the PANSS-EC total scores (zotepine, -10.1 [4.7], P < 0.001; risperidone, -8.0 [5.3], P < 0.001) and PANSS total scores (zotepine, -34.7 [15.8], P < 0.001; risperidone, -28.6 [14.3], P < 0.001). However, there were no significant differences in PANSS-EC total score (P = 0.265) and PANSS total score (P = 0.125) changes from baseline to study end point between the 2 treatment groups. Serum uric acid and prolactin decreased more in the zotepine group than the risperidone group (P < 0.001 and P = 0.018, respectively).Zotepine seemed to be as effective as risperidone in treating hospitalized, acutely ill, schizophrenic patients with agitation, and had the advantages of lowering hyperuricemia and hyperprolactinemia. Double-blind, fixed dose studies with a larger sample size of acutely ill, schizophrenic patients with agitation are needed to confirm the study results.
authors.affiliation: From the *Department of General Psychiatry, Taoyuan Mental Hospital, Taoyuan County; †Department of Psychiatry, National Taiwan University Hospital and School of Medicine, National Taiwan University, Taipei; ‡Department of Psychology, Chung Yuan Christian University, Chung-Li; §Bali Psychiatric Center; ∥Taipei City Psychiatric Center, Taipei City Hospital; ¶Institute of Public Health and Department of Public Health, College of Medicine, National Yang-Ming University; and #Institute of Neuroscience, College of Science, National Chengchi University, Taipei, Taiwan.
authors.forename: Hung-Yu
authors.initials: HY
authors.lastname: Chan
authors.forename: An-Sheng
authors.initials: AS
authors.lastname: Lin
authors.forename: Kun-Po
authors.initials: KP
authors.lastname: Chen
authors.forename: Jror-Serk
authors.initials: JS
authors.lastname: Cheng
authors.forename: Ying-Yeh
authors.initials: YY
authors.lastname: Chen
authors.forename: Chang-Jer
authors.initials: CJ
authors.lastname: Tsai
mesh_terms: D000208:Acute Disease; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003988:Dibenzothiepins / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006760:Hospitalization; D006801:Humans; D006966:Hyperprolactinemia / Q000188:drug therapy; D033461:Hyperuricemia / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy* / Q000209:etiology; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003988:Dibenzothiepins; D018967:Risperidone; C022172:zotepine